Fexofenadine HCl
- Product NDC
- 69230-202
- 11-digit product format
- 692300202
- Labeler code
- 69230
- Product ID
- 69230-202_09845f21-f05e-34b2-e063-6394a90a7677
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Fexofenadine HCl
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- Camber Consumer Care
- Application
- ANDA204507
- Marketing category
- ANDA
- Marketing start
- 2015-09-16
- Substance
- FEXOFENADINE HYDROCHLORIDE
- Active strength
- 180 mg/1
- Pharmacologic classes
- Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 69230-202-30 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 69230-202-11 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 69230-202-45 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 69230-202-90 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 69230-202-01 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 69230-202-05 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 69230-202-60 | e2bbac7714bc… | 27bdfed8d636… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded product | product | 9bebd1f3094a… | 5416666fcb17… | |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 69230-202-30 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 69230-202-11 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 69230-202-45 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 69230-202-90 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 69230-202-01 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 69230-202-05 | 9bebd1f3094a… | 5416666fcb17… |
| 2020-06-10 20:45 UTC · source 2020-06-10 | excluded package | package | 69230-202-60 | 9bebd1f3094a… | 5416666fcb17… |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2015-09-16 | ||
| A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2015-09-16 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-004 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204507-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2015-09-16 | 5bbf6a4d5a75… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fexofenadine HCl
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| FEXOFENADINE HYDROCHLORIDE | 180 mg/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2S068B75ZU | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1bb1bea3-b17d-4326-b037-7468add0df80 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| b893258d-0942-3d8a-3411-056ea0788ff5 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 69230-202-01 | Fexofenadine HCl | 100 in 1 BOTTLE | TABLET, FILM COATED | 100 | 3 | |
| 69230-202-01 | Fexofenadine HCl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 69230-202-05 | Fexofenadine HCl | 500 in 1 BOTTLE | TABLET, FILM COATED | 500 | 3 | |
| 69230-202-11 | Fexofenadine HCl | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | 3 | |
| 69230-202-30 | Fexofenadine HCl | 30 in 1 BOTTLE | TABLET, FILM COATED | 30 | 3 | |
| 69230-202-30 | Fexofenadine HCl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 69230-202-45 | Fexofenadine HCl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 69230-202-45 | Fexofenadine HCl | 45 in 1 BOTTLE | TABLET, FILM COATED | 45 | 3 | |
| 69230-202-60 | Fexofenadine HCl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 | |
| 69230-202-60 | Fexofenadine HCl | 60 in 1 BOTTLE | TABLET, FILM COATED | 60 | 3 | |
| 69230-202-90 | Fexofenadine HCl | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | 3 | |
| 69230-202-90 | Fexofenadine HCl | 1 in 1 CARTON | TABLET, FILM COATED | 1 | 3 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 69230-202-01 | EA - Each | 69230-202 | 83484e5c-4840-461c-91cb-f7f8b309cbd6 | 1 | 2018-02-20 |
| 69230-202-30 | EA - Each | 69230-202 | 0bfc5135-5b54-4d96-b2ed-9bdac16e0637 | 1 | 2018-02-20 |
| 69230-202-60 | EA - Each | 69230-202 | 4e8881ff-d9f4-4224-b74c-f9ef0e3d3e4b | 1 | 2020-07-13 |
DailyMed Dashboard NDC Coverage#
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Curist Allergy Relief | FEXOFENADINE HYDROCHLORIDE 180 MG | Little Pharma, Inc. | f8228938-b5e3-0fa8-e053-6294a90a1d7c | 2024-11-15 | Warnings | 204507 ANDA204507 |
| Fexofenadine HCl | FEXOFENADINE HCL | Advanced Rx LLC | c067b335-79c5-4176-a0b3-bae02a0c23f8 | 2024-09-10 | Warnings | 204507 ANDA204507 |
| Fexofenadine HCL | FEXOFENADINE HCL | Akron Pharma Inc. | 08023b99-0634-4ac9-afd6-4f2d2e0d2c8a | 2024-08-20 | Warnings | 204507 ANDA204507 |
| Allergy Relief | FEXOFENADINE HYDROCHLORIDE | Magno-Humphries, Inc. | 1f8a2f98-7eba-48df-9589-58587d67ae0e | 2024-01-03 | Warnings | 204507 ANDA204507 |
| Fexofenadine HCl | FEXOFENADINE HCL | Camber Consumer Care | 1bb1bea3-b17d-4326-b037-7468add0df80 | 2023-11-06 | Warnings | 204507 ANDA204507 69230-202 |
| Allergy Relief | FEXOFENADINE HCL | Allegiant Health | 61eebc8a-8d1e-48a2-afb1-eda9cb00ff97 | 2020-07-27 | Warnings | 204507 ANDA204507 |
| Fexofenadine HCl | FEXOFENADINE HCL | Proficient Rx LP | 3b147968-c6a8-4725-89b6-2eb443900e8f | 2019-11-01 | Warnings | 204507 ANDA204507 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 53beda1f-3aa1-4ba9-ae70-d69b6fbe4ebc | 18 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 53beda1f-3aa1-4ba9-ae70-d69b6fbe4ebc | 18 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 53beda1f-3aa1-4ba9-ae70-d69b6fbe4ebc | 18 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 1bb1bea3-b17d-4326-b037-7468add0df80 | 3 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | PSN | 3b147968-c6a8-4725-89b6-2eb443900e8f | 3 |
| 997501 | fexofenadine HCl 60 MG Oral Tablet | PSN | 1bb1bea3-b17d-4326-b037-7468add0df80 | 3 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 1bb1bea3-b17d-4326-b037-7468add0df80 | 3 |
| 997420 | fexofenadine hydrochloride 180 MG Oral Tablet | SCD | 3b147968-c6a8-4725-89b6-2eb443900e8f | 3 |
| 997501 | fexofenadine hydrochloride 60 MG Oral Tablet | SCD | 1bb1bea3-b17d-4326-b037-7468add0df80 | 3 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 1bb1bea3-b17d-4326-b037-7468add0df80 | 3 |
| 997420 | fexofenadine HCl 180 MG 24 HR Oral Tablet | SY | 3b147968-c6a8-4725-89b6-2eb443900e8f | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 69230-202-01 | 69230020201 | 1 BOTTLE in 1 CARTON (69230-202-01) / 100 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2015-09-16 | 0000-00-00 | No | No | Current |
| 69230-202-05 | 69230020205 | 500 TABLET, FILM COATED in 1 BOTTLE (69230-202-05) | 2015-09-16 | 0000-00-00 | No | No | Current | |
| 69230-202-11 | 69230020211 | 1000 TABLET, FILM COATED in 1 BOTTLE (69230-202-11) | 2015-09-16 | 0000-00-00 | No | No | Current | |
| 69230-202-30 | 69230020230 | 1 BOTTLE in 1 CARTON (69230-202-30) / 30 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2015-09-16 | 0000-00-00 | No | No | Current |
| 69230-202-45 | 69230020245 | 1 BOTTLE in 1 CARTON (69230-202-45) / 45 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2015-09-16 | 0000-00-00 | No | No | Current |
| 69230-202-60 | 69230020260 | 1 BOTTLE in 1 CARTON (69230-202-60) / 60 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2015-09-16 | 0000-00-00 | No | No | Current |
| 69230-202-90 | 69230020290 | 1 BOTTLE in 1 CARTON (69230-202-90) / 90 TABLET, FILM COATED in 1 BOTTLE | 1 bottle | 2015-09-16 | 0000-00-00 | No | No | Current |